1
EXHIBIT 10.68
FINISHED GOODS SUPPLY AGREEMENT
[(_________)]
This Finished Goods Supply Agreement (the "Agreement") dated this 29th day
of March, 2000 between Xxxxxx Pharmaceuticals, Inc., a Nevada corporation,
("Xxxxxx") and Xxxxxx Drug Co., Inc., a New York corporation ("Xxxxxx").
RECITALS
X. Xxxxxx and Xxxxxx have entered into a Product Purchase Agreement and
an Active Ingredient Supply Agreement, each of even date herewith, pursuant to
which (i) Xxxxxx has sold, and Xxxxxx has purchased the Product Assets, as
defined in the Product Purchase Agreement, relating to an ANDA formulation for
[___________________] and (ii) Xxxxxx will manufacture and supply to Xxxxxx the
active pharmaceutical ingredient [______________________].
X. Xxxxxx and Xxxxxx desire to establish a relationship, pursuant to
which Xxxxxx (or its appropriate Affiliates) will supply, and Xxxxxx (or its
appropriate Affiliates) will purchase, the Commercial Products, as defined
herein.
In consideration of the foregoing premises, and the mutual covenants and
obligations set forth herein, Xxxxxx and Xxxxxx hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1. "AFFILIATE" shall mean, with respect to any party, any person or
entity which, directly or indirectly through one or more intermediaries,
controls, is controlled by, or is under common control with, such party. A
person or entity shall be deemed to control a corporation (or other entity) if
such person or entity possesses, directly or indirectly, the power to direct or
cause the direction of the management and policies of such corporation (or other
entity) whether through the ownership of voting securities, by contract or
otherwise.
1.2. "ANDA" shall mean the Abbreviated New Drug Application No. [____] for
[___________________] filed with the FDA by Xxxxxx and assigned to Xxxxxx or its
Affiliate, and any supplements thereto.
1.3. "COMMERCIAL PRODUCTS" shall mean either or both of the NDA and ANDA
formulations of [______________________] in capsule form for oral
administration, packaged, labeled and finished to meet the Commercial Product
Specifications, and includes samples and trade packaging.
1.4. "COMMERCIAL PRODUCT SPECIFICATIONS" shall mean the specifications for
the relevant Commercial Product set forth in Exhibit A attached hereto,
including (as applicable) statements of pharmaceutical manufacturing, Labeling,
filling, Packaging, storage and quality control procedures, and labeling and
packaging specifications (as such may be revised from time to time in accordance
with the terms of this Agreement by written agreement executed by the parties).
2
1.5. "CONFIDENTIAL INFORMATION" shall mean, with respect to a party, all
information of any kind whatsoever (including without limitation, data,
compilations, formulae, models, patent disclosures, procedures, processes,
projections, protocols, results of experimentation and testing, specifications,
strategies and techniques), and all tangible and intangible embodiments thereof
of any kind whatsoever (including without limitation, apparatus, compositions,
documents, drawings, machinery, patent applications, records and reports), which
is disclosed by such party to the other party and is marked, identified as or
otherwise acknowledged to be confidential at the time of disclosure to the other
party. Notwithstanding the foregoing, Confidential Information of a party shall
not include information which the other party can establish by written
documentation (a) to have been publicly known prior to disclosure of such
information by the disclosing party to the other party, (b) to have become
publicly known, without fault on the part of the other party, subsequent to
disclosure of such information by the disclosing party to the other party, (c)
to have been received by the other party at any time from a source, other than
the disclosing party, rightfully having possession of and the right to disclose
such information, (d) to have been otherwise known by the other party prior to
disclosure of such information by the disclosing party to the other party, or
(e) to have been independently developed by employees or agents of the other
party without the use of such information disclosed by the disclosing party to
the other party.
1.6. "FDA" shall mean the United States Food and Drug Administration, and
any successor agency thereto.
1.7. "GMP" shall mean current Good Manufacturing Practices promulgated by
the FDA, and their equivalent promulgated by the governing health authority of
any other country in which the Commercial Products are manufactured by Xxxxxx
under this Agreement.
1.8. "XXXXXX INTELLECTUAL PROPERTY" shall mean the Intellectual Property
obtained by, or licensed to, Xxxxxx under the Product Purchase Agreement.
1.9. "INTELLECTUAL PROPERTY" shall mean Xxxxxx'x and its Affiliates' rights
existing as of the date hereof and as may be developed hereafter in and to all
confidential or proprietary information, trade secrets, patent rights,
technology, know-how, developments, improvements, techniques, data, methods,
processes, instructions, formulae, recipes, drawings and specifications
necessary to manufacture and supply the Commercial Product hereunder, and shall
include the Xxxxxx Intellectual Property.
1.10. "LABEL", "LABELED" OR "LABELING" shall mean all labels and other
written, printed or graphic matter upon (i) the Commercial Product or any
container or wrapper utilized with the Commercial Product, or (ii) any written
material accompanying the Commercial Product, including, without limitation,
package inserts.
1.11. "LIMITED WARRANTY" shall have the meaning defined in Section 2.6(c)
hereof.
1.12. "PACKAGING" shall mean all primary containers, including blisters,
cartons, shipping cases or any other like matter used in packaging or
accompanying the Commercial Products.
2
3
1.13. "PERSON" shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.
1.14. RAW MATERIAL COST" shall mean the cost of raw materials used to
manufacture the Commercial Products, determined in accordance with generally
accepted accounting principles and consistent with Xxxxxx'x accounting practices
for other products manufactured.
1.15. "REGULATORY DOSSIERS" shall mean all registrations, permits,
licenses, authorizations, approvals, presentations, notifications or filings
(together with all applications therefor), which are filed with or granted by
the governing health authority of any country, and which are required to
develop, make, use, sell, import or export the Commercial Products, other than
the Drug Master File.
ARTICLE 2
MANUFACTURE, SUPPLY AND PURCHASE
2.1. LICENSE GRANT. Xxxxxx hereby grants to Xxxxxx a non-exclusive license
to use and practice the Intellectual Property solely to manufacture the
Commercial Products for Xxxxxx in accordance with the provisions of this
Agreement. Xxxxxx makes no representation or warranty that the Intellectual
Property licensed hereunder is sufficient to allow Xxxxxx to perform its
obligations hereunder. Except as provided in this Section 2.1, Xxxxxx
acknowledges that it has no intellectual property rights in the Commercial
Products.
2.2. SUPPLY AND PURCHASE OBLIGATIONS. During the applicable term of this
Agreement, Xxxxxx shall manufacture and supply formulations of
[____________________] in capsule form for oral administration exclusively for
Xxxxxx. Xxxxxx shall purchase its requirements of Commercial Product exclusively
from Xxxxxx unless Xxxxxx fails to supply conforming Commercial Products as
Xxxxxx orders pursuant to Section 2.5(c) below (subject to Section 2.5(b) below)
for any two (2) out of four (4) consecutive calendar quarters. Xxxxxx shall have
no obligation to purchase Commercial Products under this Agreement, except to
the extent Xxxxxx provides to Xxxxxx purchase orders pursuant to Section 2.5(c)
below, provided however, that to the extent Xxxxxx purchases
[____________________] from Xxxxxx pursuant to the Active Ingredient Supply
Agreement [(_________)] of even date herewith, it shall not use such
[__________] except to supply Xxxxxx for manufacture of Commercial Products
hereunder (subject to Xxxxxx'x continued performance under this Agreement and as
otherwise permitted under the Active Ingredient Supply Agreement).
2.3. MANUFACTURING PRACTICES.
(a) Commercial Product Specifications. Xxxxxx shall manufacture,
fill, package, label and warehouse the Commercial Products in conformity with
the Commercial Product Specifications and in accordance with all applicable laws
and regulations.
(b) GMP. Xxxxxx shall manufacture the Commercial Products in
accordance with GMP and the Drug Master File. Xxxxxx shall advise Xxxxxx of any
proposed process changes outside the Drug Master File prior to their
implementation by Xxxxxx. Xxxxxx shall
3
4
have the right, at its sole expense, to audit Xxxxxx for compliance with GMP on
reasonable notice during normal business hours at least once in each calendar
year, and more often in Xxxxxx'x reasonable discretion.
(c) Active Pharmaceutical Ingredient. Xxxxxx shall use as the active
pharmaceutical ingredient [___________________] as instructed by Xxxxxx and may
be either such ingredient manufactured by Xxxxxx or supplied by a third party.
(d) Certificates of Analysis. Xxxxxx shall provide Xxxxxx with a
certificate of analysis for each shipment of the Commercial Products
manufactured and supplied hereunder based upon a reference standard established
by Xxxxxx and reasonably acceptable to Xxxxxx.
(e) Quality Control Information. Upon the reasonable request of
Xxxxxx, Xxxxxx shall provide Xxxxxx with such information, including analytical
and manufacturing documentation, requested by Xxxxxx regarding quality control
of the Commercial Products supplied hereunder.
(f) Packaging Control. In addition to its obligations pursuant to
Sections 2.3(d) and (e), Xxxxxx will evaluate and inspect each batch of
Commercial Products in accordance with Packaging guidelines set forth in the
Commercial Product Specifications and will provide Xxxxxx with a Commercial
Product lot release.
(g) Inspection. Xxxxxx, or its designee, may, at its own expense,
with prior reasonable notice and during regular business hours, visit the
facilities used by Xxxxxx to manufacture Commercial Products to review the
Commercial Product related records and the facilities.
(h) Technical Requirements. In addition Xxxxxx shall comply with the
technical requirements set forth on Exhibit B.
2.4. LABELING AND PACKAGING.
(a) Labeling. Each Commercial Product and all Labeling, advertising
and promotional material used in connection therewith, shall conform to the
Commercial Product Specifications. Xxxxxx shall be responsible for ensuring the
accuracy of all information contained on all Labels and Labeling for the
Commercial Products and for the compliance of all such Labels and Labeling with
applicable law. Should Xxxxxx desire or be required to make any change in any
such Label or Labeling, Xxxxxx shall be responsible for the updating of all
artwork and text associated with such change and providing such changes to
Xxxxxx or its Affiliates. Xxxxxx shall make all necessary arrangements for such
changed Labels or Labeling to be printed and shall provide to Xxxxxx printer's
proofs for Xxxxxx'x review. Xxxxxx shall promptly either provide Xxxxxx any
necessary corrections thereto or notify Xxxxxx of its approval of such proofs.
Xxxxxx shall reimburse Xxxxxx for the cost of preparing the proofs of such new
Labels or Labeling, as well as all other costs associated with such new Labels
or Labeling.
(b) Packaging. Xxxxxx shall supply all Packaging and Labels for the
Commercial Products under this Agreement and such Packaging and Labels shall be
in accordance with the Commercial Product Specifications.
4
5
2.5. FORECASTS AND ORDERS.
(a) Forecasts. Not less than forty-five (45) days prior to the first
day of each calendar quarter, Xxxxxx shall prepare and provide Xxxxxx with a
written forecast of the estimated Commercial Product requirements of Xxxxxx and
its Affiliates for each of the following four (4) calendar quarters. Such
forecast shall constitute a binding purchase obligation of Xxxxxx with respect
to the next upcoming quarter only.
(b) Supply Obligation. Each calendar quarter, Xxxxxx shall be
required to manufacture, supply and deliver to Xxxxxx such quantities of
Commercial Products as Xxxxxx orders pursuant to Section 2.5(c) below, up to one
hundred and twenty-five percent (125%) of the quantity forecasted for such
calendar quarter in the most recent forecast under Section 2.5(a) above. Xxxxxx
shall use its commercially reasonable efforts to manufacture, supply and deliver
to Xxxxxx any quantities of Commercial Products as Xxxxxx orders pursuant to
Section 2.5(c) below, in excess of one hundred and twenty five percent (125%) of
the quantity forecasted for such calendar quarter in the most recent forecast
under Section 2.5(a) above. If Xxxxxx becomes aware of any circumstances that
may cause Xxxxxx to default in its obligation above to deliver such quantities
of conforming Commercial Products as Xxxxxx orders for any calendar quarter,
Xxxxxx shall give Xxxxxx prompt written notice describing such circumstances,
together with a proposed course of action to remedy such failure.
(c) Orders. Xxxxxx shall make all purchases hereunder by submitting
firm purchase orders to Xxxxxx. Each such purchase order shall be in writing in
a form reasonably acceptable to Xxxxxx, and shall specify the description of the
Commercial Product(s) ordered (e.g. branded or generic product, etc.), the
quantity ordered, the price therefor under Section 3.1 below, the place of
delivery and the required delivery date therefor, which shall not be less than
sixty (60) days after the date of such purchase order. In the event of a
conflict between the terms and conditions of any purchase order and this
Agreement, the terms and conditions of this Agreement shall prevail.
1.6. DELIVERY AND ACCEPTANCE.
(a) Delivery. All Commercial Products supplied under this Agreement
shall be shipped F.O.B. Xxxxxx'x place of manufacture to such location as
designated by Xxxxxx in the applicable purchase order. Xxxxxx shall pay all
freight, insurance charges, taxes, import and export duties, inspection fees and
other charges applicable to the sale and transport of Commercial Products
purchased by Xxxxxx hereunder. Title and risk of loss and damages to Commercial
Products purchased by Xxxxxx hereunder shall pass to Xxxxxx upon delivery to
Xxxxxx'x designated carrier.
(b) Rejection and Cure. If a shipment of Commercial Products or any
portion thereof fails to conform to the applicable Commercial Product
Specifications, then Xxxxxx shall have the right to reject such nonconforming
shipment of Commercial Products or the nonconforming portion thereof, as the
case may be. Xxxxxx shall give written notice to Xxxxxx of its rejection
hereunder, within forty five (45) days after Xxxxxx'x receipt of such shipment,
specifying the grounds for such rejection. The nonconforming shipment of
Commercial Products, or the nonconforming portion thereof, shall be held for
Xxxxxx'x disposition, or shall be
5
6
returned to Xxxxxx, in each case at Xxxxxx'x expense, as directed by Xxxxxx.
Xxxxxx shall use its commercially reasonable efforts to replace each
nonconforming shipment of Commercial Products, or the nonconforming portion
thereof, with conforming Commercial Products as soon as reasonably practicable
after receipt of notice of rejection thereof, and in any event shall do so
within forty five (45) days after receipt of notice of rejection thereof.
(c) Warranty. Xxxxxx warrants that (a) Commercial Products
manufactured hereunder shall conform with the Commercial Product Specifications;
(b) Commercial Products shall be manufactured hereunder in accordance with all
applicable laws and regulations, GMP and the Regulatory Dossier; and (c) the
manufacture and sale of Commercial Products by Xxxxxx hereunder, and the use
thereof by Xxxxxx and its Affiliates contemplated hereby, shall not infringe the
patent rights of any Person or constitute a misappropriation of the trade
secrets or other intellectual property rights of any Person, except for any such
infringement or misappropriation arising directly from Xxxxxx'x use of
Intellectual Property (excluding for purposes hereof, the Xxxxxx Intellectual
Property) (collectively, parts (a), (b) and (c) above comprise the "Limited
Warranty"). XXXXXX MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT
TO THE COMMERCIAL PRODUCTS INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY OR WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
(d) Cover. If Xxxxxx fails to timely deliver to Xxxxxx the quantity
of conforming Commercial Products that Xxxxxx orders under any purchase order
pursuant to Section 2.5(c) above (subject to the provisions of Section 2.5(b)
above), after providing written notice to Xxxxxx, Xxxxxx shall have the right to
purchase substitute Commercial Products from a third party in substitution for
the quantity of conforming Commercial Products which Xxxxxx failed to deliver
hereunder. Xxxxxx shall reimburse Xxxxxx on demand for the difference between
the cost of obtaining such substitute Commercial Products (plus any commercially
reasonable charges, expenses or commissions incurred by Xxxxxx in connection
with effecting cover, and any other reasonable expenses incident to such
failure), less the price which would have been due to Xxxxxx for the like
quantity of Commercial Products if supplied by Xxxxxx hereunder.
2.7. Samples. For a period of three (3) years from the date hereof Xxxxxx
shall pay to Xxxxxx a fixed fee of[____________________________________________]
on the first (1st) day of each calendar quarter for samples. Such obligations
shall commence in the first calendar quarter in which Xxxxxx ships samples to
Xxxxxx in compliance with this Section 2.7. In consideration thereof, during
such period Xxxxxx shall supply Xxxxxx such reasonable number of samples of
Commercial Products as Xxxxxx may order, in such packaging as Xxxxxx reasonably
specifies.
ARTICLE 3
PRICE AND PAYMENT TERMS
3.1. PRICE. Xxxxxx shall purchase from Xxxxxx all Commercial Products which
are accepted pursuant to Section 2.6 above at a price equal to
[___________________________________________________________________]. On each
anniversary of the date hereof, Xxxxxx may increase such price to reflect any
increase in the Raw Material Cost during the
6
7
preceding year. Such new price shall be effective for all orders received by
Xxxxxx thirty (30) days after written notice of such increase by Xxxxxx to
Xxxxxx, such notice, showing in reasonably specific detail the calculation of
such increase.
3.2. INVOICING. Upon shipment of Commercial Products to Xxxxxx, Xxxxxx
shall submit invoices therefor to Xxxxxx. Xxxxxx shall pay each invoice in full
within forty five (45) days after the date of invoice. All payment shall be made
in U.S. Dollars.
3.3. SALES AND USE TAXES. Xxxxxx shall be solely responsible for the
payment of all federal, state, or local sales, use or value-added tax, excise or
similar charge, or other tax assessment (other than that assessed against
income), assessed or charged on the sale of Commercial Products sold pursuant to
this Agreement.
3.4. AUDIT RIGHT. Upon the written request of Xxxxxx and not more than once
in each calendar year, Xxxxxx shall permit an independent certified public
accounting firm, selected by Xxxxxx and reasonably acceptable to Xxxxxx to have
access during normal business hours to such of the records of Xxxxxx as may be
reasonably necessary to verify the accuracy of Xxxxxx'x calculation of any price
increase hereunder for any period ending not more than twenty-four (24) months
prior to the date of such request. The accounting firm shall disclose to Xxxxxx
only whether the calculations are correct or not and the specific details
concerning any discrepancies. If such accounting firm concludes that the price
increases was overstated during the audited period, Xxxxxx shall reimburse
Xxxxxx for the amount overpaid by Xxxxxx hereunder for such period within thirty
(30) days of the date Xxxxxx delivers to Xxxxxx such accounting firm's written
report so concluding. The fees and expenses charged by such accounting firm
shall be paid by Xxxxxx; provided, however, if the audit discloses that the
price increase was overstated during the audited period by more than five
percent (5%), then Xxxxxx shall pay the reasonable fees and expenses charged by
such accounting firm.
ARTICLE 4
FURTHER OBLIGATIONS OF THE PARTIES
4.1. DRUG MASTER FILE, REGULATORY DOSSIERS. Xxxxxx has filed, shall be
solely responsible for maintaining, and shall maintain the Drug Master File.
Xxxxxx shall have the nonexclusive right to reference the Drug Master File in
all applicable Regulatory Dossiers for Commercial Products. All such Regulatory
Dossiers shall be owned by Xxxxxx and Xxxxxx shall have no rights therein except
as set forth herein.
4.2. FACILITY QUALIFICATION. Xxxxxx shall, at no cost to Xxxxxx, take all
such actions to qualify (and thereafter to maintain qualification of) the
facility (or facilities) at which Xxxxxx manufactures Commercial Products
hereunder, as required under applicable law in the United States and each other
country in which Xxxxxx has informed Xxxxxx that Xxxxxx intends to sell
Commercial Products, to enable Xxxxxx to obtain and maintain all applicable
Regulatory Dossiers for the Commercial Products.
4.3. REGISTRATION ASSISTANCE. Upon the reasonable request of Xxxxxx, Xxxxxx
promptly shall, at no cost to Xxxxxx, provide Xxxxxx with such information,
samples and technical assistance, and otherwise reasonably cooperate with
Xxxxxx, in connection with the
7
8
preparation, prosecution and maintenance of all applicable Regulatory Dossiers
for the Commercial Products.
4.4. RECALL. In the event either party believes it may be necessary to
conduct a recall, field correction, market withdrawal, stock recovery, or other
similar action with respect to any Commercial Products which were sold by Xxxxxx
or its Affiliates to Xxxxxx or its Affiliates under this Agreement (a "Recall"),
Xxxxxx and Xxxxxx shall consult with each other as to how best to proceed, it
being understood and agreed that the final decision as to any Recall of any
Commercial Product shall be made by Xxxxxx; provided, however, that Xxxxxx shall
not be prohibited hereunder from taking any action that it is required to take
by applicable law. Xxxxxx shall bear all costs in connection with any such
Recall; provided, however, that Xxxxxx shall reimburse Xxxxxx for all reasonable
out-of-pocket expenses incurred by Xxxxxx in connection with any such Recall
attributable to any breach by Xxxxxx hereof, including without limitation,
Xxxxxx'x failure to manufacture and supply any Commercial Products in accordance
with the Limited Warranty.
4.5. FURTHER OBLIGATIONS OF XXXXXX. During the term of this Agreement,
Xxxxxx shall:
(a) At its own expense, promptly respond to all reasonable inquiries
from Xxxxxx pertaining to the supply of Commercial Product.
(b) Without limiting the other provisions of this Agreement, use its
commercially reasonable efforts at all times to minimize Commercial Product
delivery time.
(c) Furnish to Xxxxxx current copies of all issued master batch
records, procedures, specifications and methods and standard operating
procedures related to the Commercial Product and submit to Xxxxxx for written
approval prior to implementation any and all proposed changes to the same.
(d) Obtain Xxxxxx'x written approval prior to implementing any
proposed change in the suppliers of raw material used in the Commercial
Products, containers, Packaging, Labeling, Commercial Product Specifications,
manufacturing process, testing or the facilities which are related to the
manufacturing of Commercial Products.
(e) Promptly notify Xxxxxx of any comments, responses or notices
received from the FDA, or other applicable regulatory authorities, which relate
to or may impact the Commercial Products or the manufacture of the Commercial
Products. At its own cost, obtain and maintain any and all Federal and state
regulations and/or licenses with respect to the manufacture, by Xxxxxx, of the
Commercial Products.
(f) Provide ongoing technical product and process support with
respect to the Commercial Products.
(g) Perform stability studies on at least one commercial batch of
each Commercial Product per year and provide copies of such stability reports to
Xxxxxx.
8
9
4.6. FURTHER OBLIGATIONS OF XXXXXX. During the term of this Agreement,
Xxxxxx shall:
(a) At its own expense, promptly respond to all reasonable inquiries
from Xxxxxx pertaining to the supply of Commercial Products.
(b) Assume all responsibility for maintaining the ANDA and any
supplements thereto, including making additional filings with the FDA.
(c) Use commercially reasonable efforts to, at its own cost, obtain
and maintain any and all Federal and state Regulatory Dossiers and/or licenses
with respect to the marketing, sale and distribution of the Commercial Products.
(d) Promptly notify Xxxxxx of any comments, responses or notices
received from the FDA, or other applicable regulatory authorities, which relate
to or impact the Commercial Products or the manufacture of the Commercial
Products.
ARTICLE 5
REPRESENTATIONS AND WARRANTIES
5.1. REPRESENTATIONS AND WARRANTIES. Each party hereby represents and
warrants to the other party as follows:
(a) Corporate Existence. Such party is a corporation duly organized,
validly existing and in good standing under the laws of the jurisdiction in
which it is incorporated.
(b) Authorization and Enforcement of Obligations. Such party (a) has
the corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder, and (b) has taken all
necessary corporate action on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of such party, and
constitutes a legal, valid, binding obligation, enforceable against such party
in accordance with its terms.
(c) Consents. All necessary consents, approvals and authorizations of
all governmental authorities and other Persons required to be obtained by such
party in connection with its performance of this Agreement have been obtained.
(d) No Conflict. The execution and delivery of this Agreement and the
performance of such party's obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws or regulations, and (b) do not
conflict with, or constitute a default under, any material contractual
obligation of such party.
5.2. INSURANCE. Xxxxxx and Xxxxxx shall maintain comprehensive general
liability insurance, including product liability insurance against claims
regarding the manufacture of Commercial Products under this Agreement, in such
amounts as it customarily maintains for similar products and activities. Each
party shall maintain such insurance during the term of this Agreement and
thereafter for so long as it customarily maintains insurance for itself for
similar products and activities. Each party shall cause the other party to be
named as an additional
9
10
insured under such insurance and shall provide the other party proof of such
insurance upon request. Each party shall give the other party at least thirty
(30) days notice of any cancellation, termination or change in such insurance.
Either party may substitute a self insurance program on notice to the other
party with information demonstrating the adequacy of such program.
ARTICLE 6
INDEMNIFICATION
6.1. XXXXXX'X INDEMNITY OBLIGATIONS. Xxxxxx shall defend, indemnify and
hold harmless Xxxxxx, its Affiliates and their respective successors and
permitted assigns (and the respective officers, directors, stockholders,
partners and employees of each) from and against any and all losses,
liabilities, claims, actions, proceedings, damages and expenses (including
without limitation reasonable attorneys' fees and expenses) (herein "Damages")
relating to or arising (a) from the manufacture of the Commercial Products, (b)
any breach by Xxxxxx or its Affiliates of this Agreement, including without
limitation, the failure of the Commercial Products to meet the Limited Warranty
or (c) any claims, infringement or misappropriation relating to the Xxxxxx
Intellectual Property, provided however, Xxxxxx shall have no obligation to
indemnify Xxxxxx to the extent such Damages relate Xxxxxx'x use of the
Intellectual Property (other than the Xxxxxx Intellectual Property).
6.2. XXXXXX'X INDEMNITY OBLIGATIONS. Xxxxxx shall defend, indemnify and
hold harmless Xxxxxx and its Affiliates, and their respective successors and
permitted assigns (and the respective officers, directors, stockholders,
partners and employees of each) from and against any and all Damages arising out
of (a) the handling, possession, use, marketing, distribution or sale of any
Commercial Products by Xxxxxx or its Affiliates or any of their distributors or
agents following Xxxxxx'x or its Affiliate's delivery of the Commercial Products
to Xxxxxx at Xxxxxx'x shipping point, except to the extent such Damages give
rise to an indemnification claim of Xxxxxx under Section 6.1 above, Section 6.1
of the Active Ingredient Supply Agreement, or Section 7.1 of the Product
Purchase Agreement and (b) any claims of infringement or misappropriation
relating to the Intellectual Property (other than the Xxxxxx Intellectual
Property).
6.3. INDEMNIFICATION. A party (the "indemnitee") that intends to claim
indemnification under this Article 6 shall notify the other party (the
"indemnitor") promptly in writing of any action, claim or liability in respect
of which the indemnitee believes it is entitled to claim indemnification,
provided that the failure to give timely notice to the indemnitor shall not
release the indemnitor from any liability to the indemnitee except to the extent
the indemnitor is prejudiced thereby. The indemnitor shall have the right, by
notice to the indemnitee, to assume the defense of any such action or claim
within the fifteen (15) day period after the indemnitor's receipt of notice of
any action or claim with counsel of the indemnitor's choice and at the sole cost
of the indemnitor. If the indemnitor so assumes such defense, the indemnitee may
participate therein through counsel of its choice, but at the sole cost of the
indemnitee. The party not assuming the defense of any such claim shall render
all reasonable assistance to the party assuming such defense, and all reasonable
out-of-pocket costs of such assistance shall be for the account of the
indemnitor. No such claim shall be settled other than by the party defending the
same, and then only with the consent of the other party which shall not be
unreasonably withheld; provided that the indemnitee shall have no obligation to
consent to
10
11
any settlement of any such action or claim which imposes on the indemnitee any
liability or obligation which cannot be assumed and performed in full by the
indemnitor, and the indemnitee shall have no right to withhold its consent to
any settlement of any such action or claim if the settlement involves only the
payment of money by the indemnitor or its insurer.
6.4. LIMITATIONS ON INDEMNIFICATION. Notwithstanding any contrary provision
herein:
(i) no party shall be entitled to indemnification with respect to any
claim or suit to the extent such claim or suit results from (a) its own
negligence or willful misconduct, or (b) any action to which it has consented in
writing; and
(ii) neither party shall be liable to the other for any consequential,
incidental or indirect damages, including damages for lost profits, loss of
opportunity or use of any kind, suffered by the other party, whether in
contract, tort or otherwise.
ARTICLE 7
RELATIONSHIP BETWEEN THE PARTIES
7.1 INDEPENDENT CONTRACTOR. The relationship between Xxxxxx and Xxxxxx is
solely that of buyer and seller, it being understood that each party is acting
as an independent contractor for its own account and this Agreement does not
establish a joint venture, agency, partnership or employer/employee relationship
between the parties. Neither party shall have authority to conclude contracts or
otherwise to act for or bind the other party in any manner, whatsoever, as agent
or otherwise. Any and all contracts and agreements entered into by either party
shall be for that party's sole account and risk and shall not bind the other
party in any respect.
ARTICLE 8
CONFIDENTIALITY AND PUBLIC DISCLOSURE
8.1 CONFIDENTIALITY. Except for literature and information intended for
disclosure to customers, and except as may be required to obtain government
approval to manufacture, sell or use the Commercial Products, each party will
treat as confidential the Confidential Information, and will take all necessary
precautions to assure the confidentiality of such information. Each party agrees
to return to the other party upon the expiration or termination of this
Agreement all Confidential Information acquired from such other party, except as
to such information it may be required to retain under applicable law or
regulation, and except for one copy of such information to be retained by such
party's legal department. Neither party shall, during the period of this
Agreement or for three (3) years thereafter, without the other party's express
prior written consent use or disclose any such Confidential Information for any
purpose other than to carry out its obligations hereunder. Each party, prior to
disclosure of such Confidential Information to any employee, consultant or
advisor shall ensure that such person is bound in writing to observe the
confidentiality provisions of this agreement. The obligations of confidentiality
shall not apply to information that the receiving party is required by law or
regulation to disclose, provided however that the receiving party shall so
notify the disclosing party of its intent and cooperate with the disclosing
party on reasonable measures to protect the confidentiality of the information.
11
12
8.2 PUBLIC DISCLOSURE. Except for such disclosure as is deemed necessary,
in the reasonable judgment of a party, to comply with applicable laws, no
announcement, news release, public statement, publication, or presentation
relating to the existence of this Agreement, the subject matter hereof, or
either party's performance hereunder will be made without the other party's
prior written approval, which approval shall not be unreasonably withheld. The
parties agree that they will use reasonable efforts to coordinate the initial
announcement or press release relating to the existence of this Agreement so
that such initial announcement or press release by each is made
contemporaneously.
ARTICLE 9
TERM AND TERMINATION
9.1 TERM. Unless terminated earlier pursuant to Section 9.2 below, the
initial term of this Agreement shall expire on the date ten (10) years after the
date hereof; provided, however, that the term of this Agreement shall be
automatically extended for up to two (2) successive additional terms of five (5)
years thereafter unless either party gives to the other not less than one (1)
year's written notice of termination prior to the expiration of the initial
term, or any additional term, of this Agreement.
9.2 TERMINATION.
(a) By Either Party. A party shall have the right to terminate this
Agreement, upon or after the breach of any material provision of this Agreement
by the other party if the other party has not cured such breach within sixty
(60) days after receipt of written notice thereof from the non-breaching party.
(b) By Xxxxxx. Xxxxxx shall have the right to terminate this
Agreement, on sixty (60) days written notice to Xxxxxx, if Xxxxxx fails to
deliver to Xxxxxx such quantities of conforming Commercial Products as Xxxxxx
orders pursuant to Section 2.5(c) above (subject to the provisions of Section
2.5(b) above) for any four (4) out of eight (8) consecutive calendar quarters.
(c) Effect of Expiration and Termination. Expiration or termination
of this Agreement shall not relieve the parties of any obligation accruing prior
to such expiration or termination. The provisions of Sections 4.4, and 5.2 and
Articles 6 and 8 shall survive any expiration or termination of this Agreement.
Upon termination or expiration, each party shall immediately deliver to the
other (and cause any of its employees, agents or representatives to so deliver),
at such party's expense, all Confidential Information of the other party,
including without limitation any and all copies, duplications, summaries and/or
notes thereof or derived therefrom, regardless of the format.
ARTICLE 10
MISCELLANEOUS
10.1 NOTICES. All notices or other communications given pursuant hereto by
one party hereto to the other party shall be in writing and deemed given (a)
when delivered by messenger, (b) when sent by telecopier, (with receipt
confirmed), (c) when received by the addressee, if sent by Express Mail, Federal
Express or other express delivery service (receipt requested), or (d) five
12
13
days after being mailed in the U.S., first-class postage prepaid, registered or
certified, in each case to the appropriate addresses and telecopier numbers set
forth below (or to such other addresses and telecopier numbers as a party may
designate as to itself by notice to the other party):
If to Xxxxxx, to it at:
Xxxxxx Pharmaceuticals, Inc.
000 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Chief Operating Officer
Telecopier: (000) 000-0000
with a copy to:
Xxxxxx Pharmaceuticals, Inc.
000 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: General Counsel
Telecopier No.: (000) 000-0000
If to Xxxxxx, to it at:
Xxxxxx Drug Company, Inc.
000 X. Xxxxxxxxxx Xxxx
Xxxxxxxx, Xxxxxxxx 00000
Attention: Chief Executive Officer
Telecopier No.: (000) 000-0000
10.2 ASSIGNMENT. Neither party shall, without the prior written consent
(not to be unreasonably withheld or delayed) of the other party having been
obtained, assign or transfer this Agreement to any person or entity, in whole or
in part, provided that, each party may assign or transfer this Agreement to any
Affiliate or to any successor by merger of such party or its pharmaceutical
business, or upon a sale of all or substantially all of such parties assets, or
the assets of its pharmaceutical business, without the prior written consent of
the other party hereto. All of the terms and provisions of this Agreement shall
be binding upon and inure to the benefit of and be enforceable by the parties
hereto and their respective successors and assigns.
10.3 SEVERABILITY. If any portion of this Agreement is held invalid by a
court of competent jurisdiction, such portion shall be deemed to be of no force
and effect and the Agreement shall be construed as if such portion had not been
included herein, provided however, if the deletion of such provision materially
impairs the commercial value of this Agreement to either party, the parties
shall attempt to renegotiate such provision in good faith.
10.4 ENTIRE AGREEMENT. This Agreement and all Exhibits attached hereto
contain the sole and entire agreement and understanding of the parties hereto
and their respective Affiliates
13
14
and representatives related to the subject matter hereof and supersede all oral
or written agreements concerning the subject matter made prior to the date of
this Agreement.
10.5 AMENDMENT; WAIVER. This Agreement cannot be amended, changed, modified
or supplemented orally, and no amendment, change, modification or supplement of
this Agreement shall be recognized nor have any effect, unless the writing in
which it is set forth is signed by Xxxxxx and Xxxxxx, nor shall any waiver of
any of the provisions of this Agreement be effective unless in writing and
signed by the party to be charged therewith. The failure of either party to
enforce, at any time, or for any period of time, any provision hereof or the
failure of either party to exercise any option herein shall not be construed as
a waiver of such provision or option and shall in no way affect that party's
right to enforce such provision or exercise such option. No waiver of any
provision hereof shall be deemed to be, or shall constitute, a waiver of any
other provision, or with respect to any succeeding breach of the same provision.
10.6 GOVERNING LAW, DISPUTE RESOLUTION, ARBITRATION. This Agreement shall
be governed by, and construed in accordance with, the laws of the State of
California and the United States, as though made and to be fully performed
therein without regard to conflicts of laws principles thereof.
The parties shall initially attempt in good faith to resolve any
significant controversy, claim, allegation of breach or dispute arising out of
or relating to this Agreement (hereinafter collectively referred to as a
"Dispute") through negotiations between senior executives of Xxxxxx and Xxxxxx.
If the Dispute is not resolved within thirty (30) days (or such other period of
time mutually agreed upon by the parties) of notice of the Dispute (the
"Executive Resolution Period"), then the parties agree to submit the Dispute to
arbitration as provided herein. Unless otherwise mutually agreed by the parties,
only if the Dispute is not resolved through negotiations as set forth herein,
may a party resort to arbitration.
All Disputes relating in any way to this Agreement shall be resolved
exclusively through arbitration conducted in accordance with the Commercial
Arbitration Rule of the American Arbitration Association as then in effect. In
the event either party demands arbitration, it shall do so within thirty (30)
days after the expiration of the Executive Resolution Period (or any mutually
agreed extension) and shall include a request that such arbitration be held
within thirty (30) days of such demand. The arbitration hearing shall be held as
soon as practicable. The arbitration hearing shall be held in Orange County,
California and shall be before a single arbitrator selected by the parties in
accordance with the Commercial Arbitration Rule of the American Arbitration
Association pursuant to its rules on selection of arbitrators. The arbitrator
shall render a formal, binding non-appealable resolution and award on each issue
as expeditiously as possible but not more than ten (10) business days after the
hearing. In any arbitration, the prevailing party shall be entitled to
reimbursement of its reasonable attorneys fees and the parties shall use all
reasonable efforts to keep arbitration costs to a minimum.
10.7 SINGULAR AND PLURAL FORMS. The use herein of the singular form shall
also denote the plural form, and the use herein of the plural form shall denote
the singular form, as in each case the context may require.
14
15
10.8 HEADINGS. The headings contained in this Agreement are for convenience
of reference only and shall not constitute a part hereof or define, limit or
otherwise affect the meaning of any of the terms or provisions hereof.
10.9 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which, when
taken together, shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their respective duly authorized officers as of the date first above written.
XXXXXX PHARMACEUTICALS, INC.
By:/s/ Xxxxxx X. Xxxxxxx
Name:
-------------------------
Title: Senior Vice President
XXXXXX DRUG CO., INC.
By:/s/ Xxxxxxx Xxxxxxx
Name:
-------------------------
Title: Chief Executive Officer
15
